The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard All-silicone 3-way Foley Catheter; Bard Lubri-sil 3-way Foley Catheter; Bard Lubri-sil I.c. 3-way Foley Catheter.
| Device ID | K002868 |
| 510k Number | K002868 |
| Device Name: | BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Angela L Bunn |
| Correspondent | Angela L Bunn C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2000-12-08 |